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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
510(k) Number K931429
Device Name COOL CUT
Applicant
Mitab
Forskaregatan 1
S-275 37 Sjobo
Sweden,  SE
Applicant Contact ANNETTE MATTSSON
Correspondent
Mitab
Forskaregatan 1
S-275 37 Sjobo
Sweden,  SE
Correspondent Contact ANNETTE MATTSSON
Regulation Number878.4820
Classification Product Code
HWE  
Date Received03/22/1993
Decision Date 04/29/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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